Aptask Global Workforce (AGW) is seeking a Manufacturing Senior Associate for an Onsite position with a Global Biotechnology Company located in Thousand Oaks, CA. This is a 6+ month contract opportunity. This role will support cGMP manufacturing by providing subject-matter expertise for drug substance upstream and downstream processes involving single-use systems. The ideal candidate will have strong project management skills, technical writing experience, and the ability to troubleshoot and optimize manufacturing processes in a clean room environment.
Responsibilities: - Support manufacturing by providing subject-matter expertise for drug substance upstream and downstream processes as a Single-use SME
- Lead sophisticated projects or parts of projects using project management skills
- Resolve quick issues and execute function tests to troubleshoot and optimize processes
- Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management
- Work various shifts as instructed by the production schedule to execute function-testing and project tasks
- Work in a clean room environment following GMP documents (SOPs) with strict adherence to safety and compliance
- Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills
- Demonstrate strategic problem-solving skills and champion continual improvement
- Support New Product introduction and projects through Single Use Systems (SUS) mapping
- Support manufacturing and quality through the SUS defect/leak triage process
- Initiate and manage EN/SICAR records, working with vendors on investigations
- Maintain up-to-date trackers and manage or lead small to medium projects
Requirements: - Bachelor's Degree in Engineering or Life Sciences
- 2+ years of work experience in a GMP environment (biotech, pharma, medical device, or aerospace)
- Project management experience
- Technical writing experience
- Experience with biotech manufacturing
- Ability to work onsite in Thousand Oaks, CA
Desired skills: - Experience troubleshooting single-use materials
- Proficiency in Smartsheet, Excel, Trackwise, Visio, PI, SAP, and Spotfire
- Excellent writing and presentation skills, with experience presenting to leadership or auditors
- Technical knowledge of drug substance processing
- Experience leading and managing projects
- Understanding of Single Use Systems technologies
- Data analysis and/or data visualization skills
Pay range: up to $33.28 per hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include: - Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
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